The DOJ and FDA are seeking permanent injunctions in federal court against two of the most widespread and influential of the for-profit, unproven stem cell clinic firms in the U.S. This story is breaking so I’ll have more later this week. The take home is that I see this action as a positive, probably historic turning point for dealing with the for-profit stem cell clinic problem in the U.S. Update: US Stem Cell says it intends to fight the DOJ in court.
“One compliant (sic) was filed against U.S. Stem Cell Clinic of Sunrise, Florida, and its officers Kristin Comella and Theodore Gradel. A separate complaint was filed against Stem Cell Treatment Center of Rancho Mirage and Beverly Hills California, and its owners, Elliot Lander and Mark Berman.”
What are these businesses?
Shoot, where do I start?
I just did a post earlier today on how US Stem Cell leadership was talking in a Facebook video publicly about what seemed to potentially be a dangerous GM stem cell-based cancer vaccine. I’m still not sure if this “vaccine” exists and whether it was used in patients or was it was just an idea.
I’ve also posted extensively on US Stem Cell over the years. This blog The Niche may have issued one of the first potential red flags on this biz almost exactly three years ago in May 2015 related to its former incarnation called Bioheart getting into the direct-to-consumer stem cell biz as US Stem Cell/US Stem Cell Clinic.
In addition, I’ve written exhaustively on California Stem Cell Treatment Center and the larger group it is a key part of called Cell Surgical Network.
The FDA has now itself issued a statement as well on the new legal action, entitled, “FDA seeks permanent injunctions against two stem cell clinics.”
Here’s just part of the lengthy statement from the FDA:
“A permanent injunction is being sought against US Stem Cell Clinic LLC of Sunrise, Florida, its Chief Scientific Officer Kristin Comella and its co-owner and managing officer Theodore Gradel for marketing to patients stem cell products without FDA approval and while violating current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk. The FDA is taking this action because US Stem Cell Clinic did not address the violations outlined in a warning letter to the clinic and failed to come into compliance with the law. The FDA is seeking an order of permanent injunction requiring US Stem Cell and the individual defendants to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements.
The FDA is also seeking a permanent injunction to stop California Stem Cell Treatment Center Inc., with locations in Rancho Mirage and Beverly Hills, California; Cell Surgical Network Corporation of Rancho Mirage, California; and Elliot B. Lander, M.D. and Mark Berman, M.D., from marketing to patients stem cell products without FDA approval. Berman and Lander control the operations of approximately 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center. The FDA is seeking an order of permanent injunction requiring California Stem Cell Treatment Center Inc. and Cell Surgical Network Corporation and the individual defendants to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements.”
The inclusion of Cell Surgical Network is key here in the second action as it is a vast network of clinics that to my knowledge lack needed FDA approvals. How will this step affect the sea of Cell Surgical Network affiliated member clinics? We’ll see, but it probably could cause some to stop operations using non-FDA approved stem cells.
As I said earlier there’s a lot to digest in this breaking story and I’ll post more in the next few days, but I hope this will be a huge victory for patients who want safe, effective, as well as scientifically and medically proven stem cell treatments in coming years.
A big question is how the firms will respond and whether this could evolve into a legal battle. My guess is that the FDA/DOJ will prevail in court. I’m going to reach out to the clinic parties involved for their takes on this big federal step if they are willing to comment. Stay tuned.